; HONEYPOT Study Group. Novel use of an acellular dermal matrix allograft to treat a chronic scalp wound with bone exposure:A case study. 2018;30(9):283-289. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). 2007;(1):CD005486. J Burn Care Rehabil. Once implanted, Strattice promotes rapid revascularization [cell repopulation and white cell migration] and provides for management and strong repair ofpartial and full thickness wounds; pressure ulcers; venous ulcers; diabetic ulcer; chronic vascular ulcers; tunneled/undermined wounds; surgical wounds; trauma wounds; draining wounds; or other bleeding surface wounds. 2009;29(3):303-309. Dunschede F, et al. J Burn Care Rehabil. The combination of polytetrafluoroethylene mesh and titanium rib implants: An innovative process for reconstructing large full thickness chest wall defects. 2017;46(6):266-278, Makovicka JL, Chung AS, Patel KA, et al. Washburn R, 3rd, Anderson TM, Tokish JM. 2020;36 Suppl 1:e3283. SurGraft TL is a triple-layer amniotic tissue allograft produced from donated human amniotic membrane. Stravix/StravixPL are approximately 10 times thicker than Grafix Prime and GrafixPL Prime; and dosing recommendation is weekly for up to 12 weeks or until the wound is closed. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. 2013;100(11):1498-1504. Request to establish one new level II HCPCS code to identify a liquid human amnion and amniotic fluid allograft, Trade Name: ProMatrX ACF. Kulig KM, Luo X, Finkelstein EB, et al. The FDA generally permits products regulated solely as human tissue to be commercially distributed without premarket clearance or approval. However, there is insufficient clinical evidence to support its effectiveness. Ann Plastic Surg. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. Curr Rev Musculoskelet Med. 2013;47(6):451-453. Level of Clinical Evidence = IV. Premarket Approval Application No. The graft can be rehydrated in-situ with sterile water or 0.9% saline if desired. A retrospective clinical review of extracellular matrices for tissue reconstruction: Equine pericardium as a biological covering to assist with wound closure. Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. 2012;22(1):42-46. EpiFix for chronic wounds. 2012;16(2):267-274. Rocco G, Serra L, Fazioli F, Mori S,et al. 2013;34(5):e308. J Plast Reconstr Aesthet Surg. J Wound Care. 2022;83:104745. Evaluation of a unique bovine collagen matrix for soft tissue repair and reinforcement. Kim KD, Wright NM. 2012;78(11):1255-1260. Suprathel, a new skin substitute, in the management of donor sites of split-thickness skin grafts: Results of a clinical study. 2015;9(4):460-468. The product is supplied as 2.56 cm x 2.56 cm and 10 cm x 13 cm sizes and packaged in a primary foil pouch and secondary Tyvek pouch and sterilized by e-beam. Neonatology. 201928(3):530-538. Obes Surg. 2015;1-7. Draft for Consultation Document. 2019;32(6):272-277. Prog Urol. 2016;2:CD011255. Arch Surg. Am Surg. Characterization of a new degradable polymer scaffold for regeneration of the dermis: In vitro and in vivo human studies. Int Wound J. Abbasian B, Kazemini H, Esmaeili A, Adibi S. Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats. Both the thin and thick membranes are supplied in the following sizes: 1 x1 cm; 2 X 2 cm; 2 X 4 cm; 4 X 4 cm 4 X 6 cm and 4 X 8 Cm. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS). Int Wound J. Reduced pain, especially in a pediatric patient population, may be advantageous, despite increased treatment cost. 2012;2(2):105-109. Khan ZA, Nambiar A, Morley R, et al. Ritz MC, Gallegos R, Canham MB, et al. 2015;157(3):507-511. Holmes JH, 4th, Molnar JA, Shupp JW, et al. 2019;30(4):203-209. Ann Plast Surg. Restrata is available in a single use double peel package in a variety of sizes. Obes Surg. WoundEx membrane is intended to be used as a wound covering in the treatment of chronic and acute wounds. 1997;54(9):634-638. Rejuvenation of the aging lip with an injectable acellular dermal graft (Cymetra). No. 2009;11(6):584-587. Amniotic tissues contain many regenerative cytokines, growth factors, and extracellular matrix molecules including proteoglycans, hyaluronic acid, and collagens I, III, and IV. 1999 Nov;113(5):740-6. Lu and Khachemoune (2023) stated that the data on skin substitute usage for managing Mohs micrographic surgery (MMS) wounds remain limited. SurGraft TL is available in a single use package in various sizes. RECELL Autologous Cell Harvesting Device. 2013;287(6):1205-1209. Ann Plastic Surg. To address this, the ReCell Autologous Cell Harvesting Device (ReCell) was designed for use at the point-of-care (POC) to prepare a non-cultured, autologous skin cell suspension (ASCS) capable of epidermal regeneration using minimal donor skin. Burn injuries were randomly selected, partly treated with Omiderm (a polyurethane membrane) and partly treated with Suprathel. 2002;138(6):843-844. Hotta SS, Holohan TV. This innovation represents a relatively new approach to wound management by delivering a unique allograft of live human cells in a non-immunogenic structural tissue matrix. 2018;15(5):731-739. A single center experience. Burns. 2011;15(5):575-578. TissueMend for the repair or reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons, and all other indications. J Burn Care Rehabil. Thoracic wall reconstruction with Collamend in trauma: Report of a case and review of the literature. TheraGenesis is intended for the treatment of patients with chronic and traumatic wounds including but not limited to diabetic foot ulcers, venous leg ulcers, burns, and other chronic and traumatic wounds and tissue deficits. The authors concluded that this study found biologically active cryo-preserved human skin allografts to be safe and effective in treating difficult wounds with exposed bone and/or tendon. #: DOC1-000543-en-USVersion: ELanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for CuffMend Rotator Cuff Repair Augmentation SystemFile Type: Ref. TEC Assessment Program. Hammond TM, Porrett TR, Scott SM,et al. Morgan DM, Dunn RL, Fenner DE, et al. Hope WW, Zerey M, Schmelzer TM,et al. Biehl RC, Moore RD, Miklos JR,et al. National Institute for Health and Clinical Excellence (NICE). Plast Reconstr Surg. Glasberg SB, D'Amico RA. 2012;50(2):165-169. 2007;33(8):946-957. O'Meara S, Martyn-St James M. Foam dressings for venous leg ulcers. Surg Laparosc Endosc Percutan Tech. Guo Y, Chen G, Tian G, Tapia C. Sensory recovery following decellularized nerve allograft transplantation for digital nerve repair. De SK, Reis ED, Kerstein MD. Systematic reviews of wound care management: (2) dressings and topical agents used in the healing of chronic wounds. 2006;19(6):310-322. The NICE Medical Technologies Guidance recommended that additional research was needed to address the uncertainties regarding the potential benefits of the ReCell procedure/system. Cheng A, Saint-Cyr M. Comparison of different ADM materials in breast surgery. Burns. Vermeulen H, van Hattem JM, Storm-Versloot MN, Ubbink DT. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than SOC. This was a single case study on the use . A preliminary study on the effects of acellular tissue graft augmentation in acute Achilles tendon ruptures. K050355. Enduragen patch grafts for exposed orbital implants. Foreign body reaction to acellular dermal matrix allograft in biologic glenoid resurfacing. Perineal hernia repair with acellular dermal graft and suture anchor fixation. Barber FA, Herbert MA, et al.Tendon augmentation grafts: biomechanical failure loads and failure patterns. Adelaide, SA: Royal Australasian College of Surgeons, Australian Safety and Efficacy Registry of New Interventional Procedures - Surgical (ASERNIP-S); updated February 2007. Centers for Medicare & Medicaid Services (CMS). 2010;10(12):1065-1068. Am J Otolaryngol. Drugs, Biologicals, and Radiopharmaceuticals. Bond JL, Dopirak RM, Higgins J,et al. Plast Reconstr Surg Glob Open. Center for Medicare and Medicaid Services (CMS). Thirty patientswith second-degree burn injuries were included in the study. Adv Skin Wound Care. Human reticular acellular dermal matrix in the healing of chronic diabetic foot ulcerations that failed standard conservative treatment: A retrospective crossover study. J Cardiothorac Surg. Int Wound J. Adv Skin Wound Care. Int J Shoulder Surg. 2004;64(2):282-286. J Med Case Rep. 2014;8:251. XCelliStem consists of a blend of multiple extracellular matrix (ECM) source material, spleen and lung. Dumville JC, Walter CJ, Sharp CA, Page T. Dressings for the prevention of surgical site infection. Preliminary results of arthroscopic superior capsule reconstruction with dermal allograft. Integra Flowable Wound Matrix. 2004;27(1 Suppl):s145-s149. Surg Laparosc Endosc Percutan Tech. 2013;27(10):1236-1239. 2014;134(1):53-58. Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: CPB 0293 - Corneal Graft and Amniotic Membrane Transplantation, Limbal Stem Cell Transplantation, or Sural Nerve Grafting for Ocular Indications, CPB 0253 - Vocal Cord Paralysis/Insufficiency Treatments, CPB 0411 - Bone and Tendon Graft Substitutes and Adjuncts, CPB 0416 - Nerve Grafting: Selected Indications, CPB 0172 - Hyperbaric Oxygen Therapy (HBOT), CPB 0334 - Negative Pressure Wound Therapy, CPB 253 - Vocal Cord Paralysis / Insufficiency Treatments. Connolly RJ. Viscolelasticity of burned skin was elevated compared with unburned skin in the Mepilex Ag group at 1 month post burn. Acellular Matrices are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017). Waltham, MA: UpToDate; reviewed December 2020. The mean duration of days until coverage of the bone and/or tendon with granulation tissue was 36.14 (5.16 weeks) (range of 5 to 117 days). Caravaggi C, Francesco Grigoletto M, Scuderi N. Wound bed preparation with a dermal substitute (Hyalomatrix PA) facilitates re-epithelialization and haling: Results of a multicenter, prospective, observational study on complex chronic ulcers: The FAST Study. Post-excision of donor sites, all donor sites were randomly covered either by amniotic membrane or conventional dressing such as gauze soaked with topical Vaseline. J Neurosurg. Eaglstein WH, Falanga V. Tissue engineering and the development of Apligraf, a human skin equivalent. Acta Neurochir (Wien). 2007;193(3):360-363. The minimally-processed bilayer allograft contains collagen types IV, V, and VII that will promote cellular differentiation and wound healing. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers:A prospective randomized multicenter clinical trial. 2008;1(2):167-169. U.S. Food and Drug Administration (FDA). 2013;34(5):611-613. Chavarriaga LF, Lin E, Losken A,et al. Am Surg. Bell R, Desai S, House H,et al. The authors concluded that this study evaluated a novel application of topical oxygen therapy that has had a successful randomized clinical trial in patients with DFUs. Utility of acellular allograft dermis in the care of elderly burn patients. Gefasschirurgie. Clin Sports Med. Int Wound J. The Signature APatch is a cryopreserved, minimally engineered amniotic membrane allograft for homologous precision cut matrix for direct application as a would cover or physical barrier to acute or chronic wounds, including but not limited to venous leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds, burns, and wounds with exposed tendon, muscle, and/or bone. 2002;11(9):335-341. HCPCS Level II code, they should report the charges in the revenue center code for the item, typically revenue center code 270 for Medical-Surgical Supplies or revenue center code 278 for Medical-Surgical Supplies/Implants. J Pediatr Surg. Rockville, MD: FDA; March 19, 2008. World J Surg Oncol. This Clinical Policy Bulletin may be updated and therefore is subject to change. Schiefer JL, Rahmanian-Schwarz A, Schaller HE, Manoli T. A novel hand-shaped suprathel simplifies the treatment of partial-thickness burns. Use of fibrin sealants in cardiovascular surgery: A systematic review. In a retrospective study, these researchers examined the safety and effectiveness of a biologically active cryo-preserved human skin allograft for treating wounds with exposed bone and/or tendon in the lower extremities. 2014;60(9):26-38. The authors stated that this study had several drawbacks. Humanitarian Device Exemption No. 2016;42(5):953-1021. Thekkinkattil DK, Botterill I, Ambrose NS,et al. Throughout the treatment period, the average pain level was 1.9 on a 10-point scale. The authors stated that the ReCell procedure took longer than skin grafts, mainly due to the time required by trypsin to digest intercellular bonds (20 mins). Ryssel H, Germann G, Riedel K, et al. Baltimore, MD: CMS;May 18, 2011. Bladder polyps following Avaulta anterior mesh vaginal wall repair. 2012;6(2):36-44. J Diabetes Complications. Endoscopic endonasal treatment of a spontaneous temporosphenoidal encephalocele with a detachable silicone balloon. Clin Podiatr Med Surg. 2010;35(1):E25-E26. Hirsch RJ, Cohen JL. Harth KC, Rosen MJ. Foreign body reaction to artelon spacer: Case report. In addition, the draft guideline stated that the use of skin substitute treatments for the inpatient management of diabetic foot problems should only be offered as part of a clinical trial (NICE, 2011). Baseline patient (body mass index, age, gender, race, type and duration of diabetes, presence of neuropathy and/or peripheral arterial disease, tobacco use) and wound characteristics (size and duration) were recorded, and follow-up visits occurred every week for up to 20 weeks. J Neurosurg. 2014 Aug 12:1-7. Surgical management of primary thumb carpometacarpal osteoarthritis:A systematic review. Surg Endosc. #: DOC1-001032-en-USVersion: ALanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for FastThread Interference ScrewsFile Type: Ref. Centers for Medicare & Medicaid Services (CMS). Min JH, Yun IS, Lew DH, et al. 2015;8:19-23. Shitrit SB, Ramon Y, Bertasi G. Use of a novel acellular dermal matrix allograft to treat complex trauma wound:A case study. Steed DL. 13. 2010;112(2):428-433. Use of DermaMatrix graft in oculoplastic surgery. 2015;157(3):507-511. Afaneh C, Abelson J, Schattner M,et al. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. Collagen-based wound care products: Summary of INAHTA reviews. Patients in group A, with a higher mean hemoglobin A1c at study outset, experienced a longer mean time to closure (29.50) days compared with group B (26.20 days). Graft for prevention of Frey syndrome after parotidectomy: A systematic review and meta-analysis of randomized controlled trials. Plast Reconstr Surg. Wound Central. PuraPly and PuraPly AM are administered by applying the product to a wound using sutures or other fixation methods. Following application to a wound bed, the product functions to regenerate full-thickness functional skin across the entire surface, including all layers (epidermis, dermis, hypodermis), and regenerate functional appendages native to skin. 2009;123(6):1654-1658. Teflon granuloma after microvascular decompression for trigeminal neuralgia. Surgery. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact.
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